Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03610516
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2018-06-01
Brief Title:
Safety Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Lupus Nephritis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Placebo-controlled Patient and Investigator Blinded Study Investigating the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of Multiple Doses of CFZ533 in Patients With Moderately Active Proliferative Lupus Nephritis
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was to evaluate the safety tolerability pharmacokinetics pharmacodynamics and preliminary therapeutic efficacy of multiple doses of CFZ533 anti-CD40 monoclonal antibody in patients with moderately active lupus nephritis
Detailed Description:
This was a randomized subject and investigator blind placebo controlled multicenter study with multiple doses of CFZ533 administered by 1-hour intravenous infusion over a 24 week treatment period as compared to matched placebo infusion The treatment period was followed by a 24-week safety follow-up periodThe duration of the study including the screening period for each patient was approximately 53 weeks The investigational drug or placebo was administered on top of standard of care therapy for lupus nephritis
Patients were screened within 29 days of the first study drug infusion Eligibility was confirmed at the baseline visit within one week before the first dose Eligible patients were assigned a randomization number and receive the intravenous infusion within 3 days of baseline visit
Patients were screened within 29 days of the first study drug infusion Eligibility was confirmed at the baseline visit within one week before the first dose Eligible patients were assigned a randomization number and receive the intravenous infusion within 3 days of baseline visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None